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Validation of the 3D-CAM Turkish Version

Primary Purpose

Delirium, Validity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3d cam
DSM 5
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Delirium

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years and older
  • ASA Physical Status 1-3
  • Admitted to the ICU after surgery with a predicted length of stay for more than 48 h
  • MMSE ≥ 20 (to exclude dementia)

Exclusion Criteria:

  • Refused to participate
  • Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication
  • Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism
  • Deep sedation or coma
  • ASA physical status IV or V

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Delirium

    Arm Description

    Outcomes

    Primary Outcome Measures

    Assessment of delirium
    Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 13, 2021
    Last Updated
    April 20, 2021
    Sponsor
    Aydin Adnan Menderes University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04853706
    Brief Title
    Validation of the 3D-CAM Turkish Version
    Official Title
    Validation of the 3D-CAM Turkish Version in Surgical ICU Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 18, 2021 (Anticipated)
    Primary Completion Date
    October 18, 2021 (Anticipated)
    Study Completion Date
    December 18, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aydin Adnan Menderes University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    3D CAM into Turkish validity and reliability on postoperative delirium will be test as a prospective diagnostic study. After approval by Dr. Edward R. Marcantonio, (15) will translation and back-translation. The original 3D-CAM will translate into Turkish by two medical doctor .The two translational versions will be discussed and merged into a final version. Back translation will performed in regardless of any information from its original version by another two medical doctor. Both the translated and back translated versions will sent to Dr. Marcantonio for approval. Eligibility and the documentation of consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication usage. The Mini-Mental State Exam (MMSE) will be performed. Delirium assessment Delirium assessment with the 3D-CAM Before the study period, all researchers will participate online training program on 3D CAM. Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. Delirium assessment with the DSM-5 The psychiatrist investigator who was blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Delirium, Validity

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    245 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Delirium
    Arm Type
    Other
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    3d cam
    Intervention Description
    The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    DSM 5
    Intervention Description
    The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.
    Primary Outcome Measure Information:
    Title
    Assessment of delirium
    Description
    Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years and older ASA Physical Status 1-3 Admitted to the ICU after surgery with a predicted length of stay for more than 48 h MMSE ≥ 20 (to exclude dementia) Exclusion Criteria: Refused to participate Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism Deep sedation or coma ASA physical status IV or V
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    SINEM S OZTURK
    Phone
    4441256
    Email
    sarisinem@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32204700
    Citation
    Mu DL, Ding PP, Zhou SZ, Liu MJ, Sun XY, Li XY, Wang DX. Cross-cultural adaptation and validation of the 3D-CAM Chinese version in surgical ICU patients. BMC Psychiatry. 2020 Mar 24;20(1):133. doi: 10.1186/s12888-020-02544-w.
    Results Reference
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    Validation of the 3D-CAM Turkish Version

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